HATFIELD, England, September 11, 2013 /PRNewswire/ --
FDA approval marks Eisai's continued investment in UK high tech drug manufacturing facility
Japanese pharmaceutical company Eisai today announces that the US Food and Drug Administration (FDA) has approved the US supply of the epilepsy drug Fycompa® (perampanel) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will manufacture six different strengths of tablet for export to the US.
The FDA supply approval for perampanel is the latest in a series of achievements for Eisai in the UK. In addition to its existing EMEA sales and marketing, R&D, and manufacturing operations in Hatfield, Eisai recently announced the construction of new 2,900m2 facility for the global packaging of potent compounds which expands the current 7,800m2 Hatfield site by nearly 40%. The Hatfield site is the Eisai EMEA headquarters and is growing in significance to the company's worldwide business, as it becomes a global supply centre for innovative new products. Perampanel was jointly developed by Japan and the UK and, as a result, Eisai continues its commitment to a long-term global business structure and investment into further research and development in the UK.
Gary Hendler, President and CEO, Eisai EMEA explains: "The FDA approval for the supply of our epilepsy drug perampanel is testament to the commitment we have made at our EMEA Knowledge Centre and the Hatfield manufacturing facility. The UK is a competitive location for advanced manufacturing and packaging and I am delighted that we are now able to export products developed and manufactured here in the UK to the US."
The FDA approval for the manufacture and supply of perampanel to the US is another example of Eisai's human health care mission; the company's commitment to increasing access to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to addressing the unmet medical needs of patients and their families.
Notes to Editors:
Eisai has a long and established history of scientific investment and partnership in the UK:
- Eisai's first investments into UK R&D began 20 years ago with a landmark partnership with the neurosciences department at University College London (UCL), established to undertake world-leading scientific research into neurodegenerative diseases. This partnership continues to this day.
- After entering a new phase in 2011, the company's Neuroscience Product Creation Unit (Neuroscience PCU) and UCL are currently engaging in joint research into neurodegenerative diseases, including biomarker research and drug discovery.
- Eisai is committed to making further contributions to address key unmet medical needs in neurosciences by maintaining and strengthening the relationship built up with UCL, whilst at the same time leveraging the knowledge accumulated over the course of the partnership for the benefit of patients and their families in Europe and beyond.
- Eisai established the £100 million EMEA Knowledge Centre (EKC), in June 2009 in Hatfield Hertfordshire. This site integrates the company's discovery research, clinical development, production, marketing, and EMEA headquarters functions with the aim of expanding business operations further in Europe and around the world
- In 2012, the Eisai Hatfield site became the first global, solid dose manufacture supply site outside of Japan for the antiepilepsy drug Fycompa (perampanel)
- In 2013, it was announced that the Eisai Hatfield site was expanding to include an additional high potency, global packaging capability to handle the blister packaging of Eisai's investigational treatment lenvatinib (E7080). Once fully developed, this site will also increase capacity to package and supply the anti-epilepsy drug (AED) Fycompa® (perampanel) and other new products, to new markets around the world.
Eisai in Oncology
Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
Eisai in Epilepsy
Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
- Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma).
- Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL).
- Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years (Rufinamide was originally developed by Novartis)
- Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).
Eisai concentrates its R&D activities in three key areas:
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, Russia, the Netherlands, Belgium, and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
Date of preparation: September 2013
Job code: Corporate-UK2017